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NCT01367509 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function
A Phase 1 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01367509: Completed Phase 1 study, sponsored by Bausch Health Americas.
NCT01367509 is a Phase 1 study that has completed, run by Bausch Health Americas. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01367509, a Phase 1 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study is evaluating the Pharmacokinetics of MNTX in healthy control subjects and in patients with mild, moderate, or severe renal impairment who do not require hemodialysis.
Primary Outcome
To compare the PK of MNTX administered subcutaneously as a single dose in patients with impaired renal function with the PK of MNTX administered to healthy subjects.
Interventions
- DRUG Methylnaltrexone (MNTX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2004-03 |
| Est. Completion | 2005-06 |
| Phase | Phase 1 |
What the finished NCT01367509 record still lists
NCT01367509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which Methylnaltrexone (MNTX) is the first listed.
NCT01367509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01367509 about?
NCT01367509 is a clinical study titled "Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function". This study is evaluating the Pharmacokinetics of MNTX in healthy control subjects and in patients with mild, moderate, or severe renal impairment who do not require hemodialysis.
What is the current status of trial NCT01367509?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2004-03. Estimated completion is 2005-06.
What interventions are being tested in trial NCT01367509?
The interventions under investigation include: Methylnaltrexone (MNTX) (DRUG).
Who is sponsoring clinical trial NCT01367509?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01367509's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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